April 15, 2016 Page 1 of 7 NIH DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES STATEMENT OF WORK BACKGROUND The National Institutes of Health (NIH) is the nation?s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people?s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts. STATEMENT OF OBJECTIVE The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the BPN and possibly other NIH drug discovery and development projects and programs: ? Bioactivity Assay ? Drug Metabolism and Pharmacokinetics SCOPE OF WORK Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. April 15, 2016 Page 2 of 7 Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on programs and projects to the NIH and to BPN LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. General Requirements Consultants may serve on BPN LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs. A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held once or twice per month to discuss programmatic issues of broad interest. Specific Discipline Requirements 1. Bioactivity Assay Bioactivity Assay consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. Bioactivity Assay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of April 15, 2016 Page 3 of 7 individual projects. Assay-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Bioactivity Assay consultant may include but is not limited to the following responsibilities and tasks: ? In partnership with other consultants, contractors, and NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND-enabling studies, and clinical studies. ? Serve as a resource to LDT for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage ? Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges. ? Collaborate on design of investigative studies in support of development compounds. 2. Drug Metabolism and Pharmacokinetics Drug Metabolism and Pharmacokinetics (DMPK) consultants may be required to evaluate PK study protocols and data, assist with study design, and advise NIH staff on the establishment of milestones related to DMPK. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. DMPK-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Drug Metabolism and Pharmacokinetics consultant may include but is not limited to the following responsibilities and tasks: ? In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage pharmacokinetic (PK) programs to facilitate assay development, exploratory chemistry, lead optimization, formulation activities, IND enabling, and clinical studies. ? Serve as the PK expert in order to identify potential drug discovery and development challenges such as lead identification and lead development and suggest strategies to address these challenges. ? Collaborate on design of investigative PK studies, PK/PD strategy, experimental design, data analysis and interpretation for discovery and translational projects in support of NIH drug discovery and development projects. QUALIFICATIONS General Experience Consultants must have extensive experience in managing or being a senior leader in drug discovery and development projects in the biopharmaceutical industry. Experience with drug April 15, 2016 Page 4 of 7 discovery and development for nervous system conditions is required. Broad experience across the entire drug discovery and development process is especially desired. Consultants must be able to work in a virtual, cross-functional team environment and manage competing priorities. Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy. Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Experiences in team leadership, consulting, or service on strategic and advisory boards will be considered. Specific Discipline Experience The following educational and experience requirements are the minimum acceptable requirements. 1. Bioactivity Assay Bioactivity Assay consultants should demonstrate high-level expertise as follows: ? An advanced degree in a scientific discipline is required ? A minimum of 20 years of experience ? Demonstrated expertise and experience in developing, implementing, and optimizing cell-based and biochemical assays for high throughput screening and safety screening ? Demonstrated hands-on experience in the application of assays in industrial pharmaceutical discovery and development; application of automated technologies and robotics relevant to pharmaceutical assays; and application of a diverse range of molecular and cellular techniques in pharmaceutical assays ? Experience working with multi-disciplinary drug development teams at a senior level in the pharmaceutical industry. ? Experience with drug discovery and development of small molecules for nervous system conditions is required. ? Experience serving in a leadership role in a virtual team environment is highly preferred. 2. Drug Metabolism and Pharmacokinetics Drug Metabolism and Pharmacokinetics consultants should demonstrate high-level expertise as follows: April 15, 2016 Page 5 of 7 ? An advanced degree in a scientific discipline is required ? A minimum of 25 years of experience. ? Demonstrated senior-level oversight of research and development efforts for small molecules ? A track-record of successfully building and leading drug development teams focused on drug metabolism and pharmacokinetics ? A significant track-record of scientific accomplishment as evidenced by publications and/or contributions to the development of marketed products. ? Experience in drug metabolism and pharmacokinetics of small molecules for nervous system conditions is required. ? Experience interacting with the FDA or other regulatory authorities preferred. Level of Effort The NIH estimates that it will require the following labor hours for each of the specific disciplines as follows: 1. Bioactivity Assay Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours 2. Drug Metabolism and Pharmacokinetics Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours Period of Performance Base Year - June 1, 2016 through May 31, 2017 Option Period One - June 1, 2017 through May 31, 2018 Option Period Two - June 1, 2018 through May 31, 2019 Option Period Three - June 1, 2019 through May 31, 2020 Option Period Four - June 1, 2020 through May 31, 2021 Travel Consultants may be asked to travel for one-day site visits for the launch of BPN projects, Executive Oversight Committee meetings for the BPN, or other travel as requested. The April 15, 2016 Page 6 of 7 consultant shall make his/her own travel arrangements. The Contracting Officer?s Representative (COR) may assist the consultant in identifying a hotel at an acceptable rate, if an overnight stay is required. The Government shall reimburse all reasonable travel costs. Airplane tickets must be purchased from a US carrier, at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses. The consultant shall make a good faith effort to select travel options that are the most time and cost-effective, given the available options. The consultant must keep food and incidental costs within the typical government per diem rate for the region. The consultant may bill up to 50% of travel hours to the Government, at the negotiated consulting rate. Travel Costs - Commercial Costs for lodging, meals, and incidental expenses incurred by Contractor personnel shall be considered to be reasonable and allowable to the extent they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulations, General Services Administration (GSA). Therefore, if travel costs are applicable, please be advised that they shall be calculated using the per diem rate schedule as established by GSA. Reimbursement of travel costs under any contract awarded from this RFP shall be in accordance with FAR 31.205-46. All travel costs shall require prior written approval of the Contracting Officer before incurrence of the cost. Intellectual Property Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator?s institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NIH COR, for documentation purposes. Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or by persons or entities applying to or accepted to the Blueprint Neurotherapeutics Network during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information through the efforts of participants in the Blueprint Neurotherapeutics Network. April 15, 2016 Page 7 of 7 IT Security Requirements Please refer to the combined synopsis solicitation for IT security requirements. The NIH may award multiple consulting contracts under this solicitation.